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The aim of this study is to evaluate efficacy and safety of transurethral resection of the prostate and bipolar enucleation of the prostate.
Endoscopic management of benign prostatic hyperplasia (BPH), monopolar transurethral resection of the prostate (TURP) has been the gold standard for many years.
Despite its promising efficacy in treating BPH, TURP is associated with a risk of significant complications and clinical limitations, including life-threatening events such as transurethral resection (TUR) syndrome, as well as high cost due to long hospital stay, long catheterization time and difficulty in management of large sized prostate so alternative surgical approaches have been explored.
Minimally invasive approaches achieve equal efficiency to standard resection, but with a more favorable safety and less complications.
Anatomical enucleation of the prostate using Bipolar or Laser-based approaches such as holmium laser have been introduced with success and the efficacy and safety of these procedure has led to the integration into several international guidelines.
Early results of bipolar enucleation resemble those reported for holmium laser procedure, Bipolar transurethral enucleation of the prostate was at least equally effective, and showed less complications, good hemostatic control and both shorter catheterization time and hospital stay than old standard procedure.
A comparison between TURP and Bipolar enucleation of prostate allows us to investigate the true benefits and safety of each modality.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Transurethral resection of prostate | Active Comparator | Transurethral resection of prostate (TURP) will be performed under spinal or general anesthesia as per usual care. |
|
| Transuretheral enucleation of prostate | Active Comparator | Transurethral enucleation of prostate (TUEP) will be performed under spinal or general anesthesia as per usual care. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TURP | Procedure | Using bipolar loop diathermy via cystoscopy, excess prostate tissue is resected piecemeal to remove obstruction to the prostatic urethra due to BPH. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Catheter and lower urinary tract symptoms free after Bipolar Transurethral resection of prostate (TURP) versus Bipolar Transurethral enucleation of prostate (TUEP) in patient with BPH with lower urinary tract symptoms | To determine number of patients in each group that will be Catheter and lower urinary tract symptoms free with changes in IPPS < 20 score after intervention and follow up at 1 month, 3 months and 6 months. | at least 6 months up to one year |
| Measure | Description | Time Frame |
|---|---|---|
| Operative time in minutes in each group of intervention | To determine operative time in minutes in each group of intervention | 60 - 90 minutes for each group of intervention |
| Compare complication rate of TURP versus TUEP |
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Inclusion Criteria:
Exclusion Criteria:
male patient with BPH
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| AHMED A.FATAH HAMED, Master's | Contact | 00201146085302 | 002 | ahmeda.hamed1991@med.svu.edu.eg |
| Mostafa A.Razik Ahmed, Doctorate | Contact | 00201004116386 | 002 | mostafa_uro@med.svu.edu.eg |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Medicine South Valley University | Recruiting | Qina | Qena Governorate | 83523 | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30816336 | Background | Zhang Y, Yuan P, Ma D, Gao X, Wei C, Liu Z, Li R, Wang S, Liu J, Liu X. Efficacy and safety of enucleation vs. resection of prostate for treatment of benign prostatic hyperplasia: a meta-analysis of randomized controlled trials. Prostate Cancer Prostatic Dis. 2019 Dec;22(4):493-508. doi: 10.1038/s41391-019-0135-4. Epub 2019 Feb 28. | |
| 17628326 |
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A comparison between TURP and Bipolar enucleation of prostate allows us to investigate the true benefits and safety of each modality.
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|
| TUEP | Procedure | Using bipolar enucleation loop diathermy via cystoscopy, to anatomically enucleate prostate. |
|
|
To determine the percentage and severity of complications after each intervention (according to the Clavien-Dindo classification).
| at least 6 months up to one year |
| Cost effectiveness of TURP versus TUEP in achieving catheter-free rates in BPH patients with urinary retention | To determine the cost required to achieve catheter free patients for each intervention (including hospitalization, anesthetic costs, equipment, consumables, etc) | at least 6 months up to one year |
| Compare patient reported symptom measures by IPSS questionnaire after TURP versus TUEP | sing International prostate symptom score (IPSS) questionnaire to determine patient reported symptom measure after each intervention minimal score: 0, maximum score is 35 higher score means worse outcome | at least 6 months up to one year |
| Compare patient reported symptom measures by Michigan Incontinence Symptom Index (M-ISI) questionnaire after TURP versus TUEP | Using the Michigan Incontinence Symptom Index (M-ISI) questionnaire to determine patient reported symptom measure after each intervention
| at least 6 months up to one year |
| Compare patient reported symptom measures by IIEF-5 questionnaire after TURP versus TUEP | Using the International index of erectile function- 5 items (IIEF-5) questionnaire to determine patient reported symptom measure after each intervention minimum score: 1, maximum score: 25 higher score means better outcome | at least 6 months up to one year |
| Compare patient reported quality of life by SF-12 questionnaire after TURP versus TUEP | sing the Short Form 12 (SF-12) questionnaire to determine patient reported quality of life measures after each intervention minimum score: 0, maximum score: 100 higher score means better outcome | at least 6 months up to one year |
| Seitz M, Sroka R, Gratzke C, Schlenker B, Steinbrecher V, Khoder W, Tilki D, Bachmann A, Stief C, Reich O. The diode laser: a novel side-firing approach for laser vaporisation of the human prostate--immediate efficacy and 1-year follow-up. Eur Urol. 2007 Dec;52(6):1717-22. doi: 10.1016/j.eururo.2007.06.028. Epub 2007 Jun 26. |
| 16126327 | Background | Bachmann A, Schurch L, Ruszat R, Wyler SF, Seifert HH, Muller A, Lehmann K, Sulser T. Photoselective vaporization (PVP) versus transurethral resection of the prostate (TURP): a prospective bi-centre study of perioperative morbidity and early functional outcome. Eur Urol. 2005 Dec;48(6):965-71; discussion 972. doi: 10.1016/j.eururo.2005.07.001. Epub 2005 Jul 18. |
| 21883820 | Background | Gilling PJ, Wilson LC, King CJ, Westenberg AM, Frampton CM, Fraundorfer MR. Long-term results of a randomized trial comparing holmium laser enucleation of the prostate and transurethral resection of the prostate: results at 7 years. BJU Int. 2012 Feb;109(3):408-11. doi: 10.1111/j.1464-410X.2011.10359.x. Epub 2011 Aug 23. |
| 31346761 | Background | Arcaniolo D, Manfredi C, Veccia A, Herrmann TRW, Lima E, Mirone V, Fusco F, Fiori C, Antonelli A, Rassweiler J, Liatsikos E, Porpiglia F, De Sio M, Autorino R; EAU Section of Uro-Technology (ESUT) Research Group. Bipolar endoscopic enucleation versus bipolar transurethral resection of the prostate: an ESUT systematic review and cumulative analysis. World J Urol. 2020 May;38(5):1177-1186. doi: 10.1007/s00345-019-02890-9. Epub 2019 Jul 25. |
| 17416453 | Background | Ho HS, Yip SK, Lim KB, Fook S, Foo KT, Cheng CW. A prospective randomized study comparing monopolar and bipolar transurethral resection of prostate using transurethral resection in saline (TURIS) system. Eur Urol. 2007 Aug;52(2):517-22. doi: 10.1016/j.eururo.2007.03.038. Epub 2007 Mar 28. |
| ID | Term |
|---|---|
| D011470 | Prostatic Hyperplasia |
| ID | Term |
|---|---|
| D011469 | Prostatic Diseases |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
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| ID | Term |
|---|---|
| D020728 | Transurethral Resection of Prostate |
| ID | Term |
|---|---|
| D011468 | Prostatectomy |
| D013521 | Urologic Surgical Procedures, Male |
| D013520 | Urologic Surgical Procedures |
| D013519 | Urogenital Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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